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June 2009

How They Did It: Pfizer's Transition from 50 Document Management Systems to One

Imagine undergoing an FDA audit requiring a search of 50 document systems for key audit items. This was the situation at Pfizer until recently, when Craig Barilla and his team began combining the company's 50 document management systems into one. Craig and associate Beth Boucher describe the execution of this Herculean task and the results of streamlining Pfizer's document systems.

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Current Political Climate Favors Passage of Drug and Device Accountability Act of 2009

Although essentially the same as its 2008 predecessor, the recently announced Drug and Device Accountability Act of 2009 is much more likely to become law in today's more favorable, "accountability-conscious" political climate. If and when this happens, the bill will subject product applications that contain false or misleading information to stiff fines (up to $5,000,000), and these fines will be assessed both to companies and their senior officers, who, in addition, will face jail sentences of up to 20 years.

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Did you know that the FDA is pursuing a future where all regulated product information will be electronic? The FDA is currently implementing numerous systems which promise to usher in a new era of electronic interactions between the agency and its constituents (i.e. industry and consumers).

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